Life sciences law,where regulationmeets the molecule.
SIRI Law LLP advises pharmaceutical manufacturers, biotech companies and clinical research organisations on drug licensing, IP protection, clinical trial agreements and manufacturing compliance.
- Free first consultation
- CDSCO aware
- Fixed-fee packages available
- Hyderabad based, India's pharma hub
Pharma & Life Sciences
Hyderabad sits at the centre of India's pharmaceutical and life sciences industry, and the regulatory framework governing it, drug licensing, clinical trials, patent protection, moves quickly. We track it closely because our clients cannot afford not to.
Pharmaceutical manufacturers
Manufacturing and marketing licence advisory and ongoing regulatory compliance.
Biotech and life sciences startups
Patent strategy and corporate structuring for research-driven companies.
Clinical research organisations
Clinical trial agreement drafting and regulatory compliance support.
Life sciences investors
Regulatory and IP due diligence for pharma and biotech investments.
Roadmap
Where we help, across the development lifecycle.
From research and IP protection through to commercial manufacturing.
- 01Research stage
Protect the innovation
IP strategy shapes commercial value years before a product reaches market.
- Patent filing strategy for pharmaceutical innovations
- Freedom-to-operate analysis
- Research collaboration and licensing agreements
- Trade secret protection for formulations and processes
- 02Development stage
Run clinical trials
Trial agreements and regulatory compliance carry particular scrutiny.
- Clinical trial agreement drafting with sites and investigators
- Informed consent documentation review
- CDSCO clinical trial approval support
- Adverse event reporting and pharmacovigilance advisory
- 03Commercialisation
License and manufacture
Manufacturing and marketing require specific regulatory approvals.
- Drug manufacturing licence advisory
- Marketing authorisation and labelling compliance
- Technology transfer and manufacturing agreements
- Quality and GMP compliance advisory
- 04Post-launch
Distribute and monitor
Distribution and ongoing safety monitoring continue after launch.
- Distribution and supply agreement drafting
- Pharmacovigilance system compliance
- Post-market surveillance obligations
- Patent enforcement against infringement
What we do
Life sciences legal, lab to market.
Regulatory and IP work for the full pharmaceutical development lifecycle.
Drug licensing advisory
Manufacturing and marketing licence guidance under CDSCO and state drug authority requirements.
- Licensing
- CDSCO
- Compliance
Clinical trial agreements
Drafting agreements with trial sites, investigators and sponsors.
- Clinical trials
- Agreements
- Sites
Patent and IP strategy
Protecting pharmaceutical innovations through patent filing and enforcement.
- Patents
- IP strategy
- Protection
Technology transfer agreements
Structuring manufacturing technology transfer and licensing arrangements.
- Technology transfer
- Licensing
- Manufacturing
Distribution and supply agreements
Contracts governing pharmaceutical distribution and supply chains.
- Distribution
- Supply
- Contracts
Pharmacovigilance compliance
Advisory on safety monitoring and adverse event reporting obligations.
- Pharmacovigilance
- Safety
- Compliance
Regulatory due diligence
Supporting investors and acquirers with regulatory and IP diligence on life sciences targets.
- Due diligence
- Investors
- M&A
Where we come in
Five mistakes we often see.
Each one creates delay or exposure in a heavily regulated industry.
Filing patents without a freedom-to-operate analysis
A patentable innovation can still infringe existing patents in the manufacturing or formulation process, creating risk discovered too late.
Clinical trial agreements silent on data ownership
Ambiguity about who owns trial data and resulting IP creates disputes between sponsors, sites and investigators after the trial concludes.
Manufacturing changes made without licence amendment
Changes to manufacturing processes or facilities can require licence amendments, and proceeding without them creates compliance exposure.
Distribution agreements that do not address pharmacovigilance obligations
Distributors often have their own adverse event reporting responsibilities that should be clearly allocated in the agreement.
Underestimating technology transfer documentation needs
Manufacturing technology transfer involves both IP licensing and regulatory approval considerations that are often addressed separately when they should be coordinated.
Ready to start?
Developing, manufacturing or investing in a life sciences product? Call for a free first consultation.
Tell us about your stage and product, and we will flag what needs attention. Calls are answered by an advocate.
Why life sciences companies choose us
We work in India's pharma hub.
Retain us for a single matter or for the long run. Either way you deal with the same accountable team.
Hyderabad-based, pharma-fluent
Located at the centre of India's pharmaceutical industry, with the regulatory familiarity that comes with it.
IP and regulatory combined
We handle both the patent strategy and the regulatory compliance that determines whether it can be commercialised.
Full lifecycle support
From early-stage research collaboration through commercial manufacturing and distribution.
Google reviews
See what our clients say on Google.
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Questions
Common questions.
General information only, not legal advice. Every situation differs, so speak to us about yours.
What licences do we need to manufacture pharmaceuticals?
This depends on the product category, but generally includes manufacturing licences from state drug authorities and, for certain products, CDSCO approval.
We review your specific product and manufacturing plans to confirm requirements.
How do we protect our formulation or process innovation?
Patent protection is the primary route, alongside trade secret protection for elements not disclosed in the patent application.
We help you decide the right strategy based on your specific innovation and commercial plans.
What should a clinical trial agreement address?
Data ownership, publication rights, indemnification, adverse event reporting responsibilities, and compensation for trial participants and sites.
We draft these to protect sponsors while meeting regulatory and ethical requirements.
Do we need CDSCO approval for our clinical trial?
Generally yes, for trials conducted in India, subject to specific requirements depending on the trial phase and product category.
We support the approval process alongside your regulatory affairs team.
Can you support investors diligencing a life sciences target?
Yes, including reviewing patent portfolios, regulatory approvals and compliance history as part of investment due diligence.
This is a specialised diligence area given the regulatory complexity involved.
How much does this cost?
Fixed-fee packages are available for common needs like agreement drafting or licensing advisory. Patent work and complex regulatory matters are scoped separately.
Fees are agreed in writing before work starts.
Related
Often needed alongside.
Life sciences legal work often involves these services too.
Healthcare
Clinical and healthcare regulatory advisory.
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IPR & Technology Law
Trademarks, patents and IP strategy.
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Manufacturing
Factory compliance and supply chain.
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Mergers & Acquisitions
Deal structuring and diligence.
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Free first consultation
Tell us about your pharma matter.
High level is fine. We check conflicts, tell you honestly whether we can help, and what it would cost. You decide, with no pressure.
- Call+91 79819 12046
- WhatsAppMessage us on WhatsApp
- Emailinfo@sirilawllp.com
- HoursMon–Sat, 9:30 AM–7:00 PM IST. Incident line 24/7.
- Existing client?Message your named lead directly, or use the incident line for anything urgent.
Thank you. We have your enquiry.
A member of our team will be in touch within one working day. For anything urgent, call +91 79819 12046.
Visit us
Find our offices.
HITEC City, Madhapur, Hyderabad, Telangana 500081
Mon to Sat, 9:30 AM to 7:00 PM IST · Meetings by appointment · Online consultations worldwide